Ignite Creation Date:
2024-05-05 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00734890
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2008-08-13
Brief Title:
Vandetanib and Bevacizumab in Treating Patients With Advanced Solid Tumors or Lymphoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Study of Vandetanib ZD 6474 and Bevacizumab Combination Therapy Evaluating the VEGF and EGF Signal Transduction Pathways in Adults With Solid Tumors and Lymphomas
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vandetanib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as bevacizumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Bevacizumab and vandetanib may also stop the growth of cancer cells by blocking blood flow to the cancer Giving vandetanib together with bevacizumab may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of vandetanib and bevacizumab in treating patients with advanced solid tumors or lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of vandetanib and bevacizumab in treating patients with advanced solid tumors or lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose safety and toxicity of vandetanib and bevacizumab in patients with advanced solid tumors or lymphoma
Secondary
Characterize the pharmacokinetic profile of this regimen in these patients
Measure changes in VEGF and other angiogenic cytokines in plasma samples from these patients
Determine the biochemical changes in the EGF signal transduction pathways in tumor biopsy samples from these patients
Determine the anti-angiogenic effects of this regimen in tumor biopsy samples from these patients
Evaluate the application of dynamic contrast-enhanced MRI to determine early changes in tumor vascular permeability during treatment
Evaluate the effects of this regimen on circulating endothelial progenitors and mature circulating endothelial cells in these patients
OUTLINE Patients receive oral vandetanib once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients undergo blood sample collection periodically for correlative laboratory studies including pharmacokinetic biomarker VEGF and other angiogenic cytokines and circulating endothelial cell analysis Patients may also undergo optional tumor biopsies for additional correlative laboratory studies
Primary
Determine the maximum tolerated dose safety and toxicity of vandetanib and bevacizumab in patients with advanced solid tumors or lymphoma
Secondary
Characterize the pharmacokinetic profile of this regimen in these patients
Measure changes in VEGF and other angiogenic cytokines in plasma samples from these patients
Determine the biochemical changes in the EGF signal transduction pathways in tumor biopsy samples from these patients
Determine the anti-angiogenic effects of this regimen in tumor biopsy samples from these patients
Evaluate the application of dynamic contrast-enhanced MRI to determine early changes in tumor vascular permeability during treatment
Evaluate the effects of this regimen on circulating endothelial progenitors and mature circulating endothelial cells in these patients
OUTLINE Patients receive oral vandetanib once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients undergo blood sample collection periodically for correlative laboratory studies including pharmacokinetic biomarker VEGF and other angiogenic cytokines and circulating endothelial cell analysis Patients may also undergo optional tumor biopsies for additional correlative laboratory studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000590152 | None | None | None |
| 08-C-0087 | None | None | None |
| NCI-P7189 | None | None | None |